medical Class II Updated 2021-08-18

Edwards Lifesciences, LLC recalls Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exteri

Recalled Product

Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US

Hazard / Issue

There is a potential for internal leaks within catheters.

Issued by

FDA

Affected States: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH
Lot/Code Info: Lot numbers: 62685542, 62685542, 63316354, 62685542, 62704123, 62685542, 62685542, 62667413, 62685542, 62704123, 62685542, 63608316, 62685542, 62704123, 62685542, 62685542, 62704123, 62685542, 62685542
View official government recall

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